Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting (HNPCC)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Case Western Reserve University
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
Vanderbilt University
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01582841
First received: December 15, 2011
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The investigators research mobilizes the resources of an integrated health-delivery system with extensive electronic clinical data to implement and evaluate a new strategy to maximize screening of Colorectal Cancer (CRC) patients for Lynch Syndrome.


Condition Intervention
Colon Cancer
Lynch Syndrome
Procedure: MSI screening test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Implementation effectiveness [ Time Frame: All patients will be followed up to 5 years. Most active participation and chart review will take place within one year of surgery. ] [ Designated as safety issue: No ]
    The primary outcomes to assess implementation effectiveness are: number of patients who receive HNPCC screening test results; number of physicians who receive their patients HPNCC screening test results; completion of the educational session at three months of follow-up; and number of patients with MSI-H (microsatellite instability-high) test results who are contacted by medical genetics.


Estimated Enrollment: 1200
Study Start Date: February 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSI testing
All individuals in the intervention arm who consent to participate in the HNPCC screening will have their tumors evaluated for MSI following surgery. Those with MSI-H results will receive a genetic counseling informational call.
Procedure: MSI screening test
All individuals in the intervention arm who consent to participate in the HNPCC screening will have their tumors evaluated for MSI.
No Intervention: Usual care
These patients will be treated as usual by their oncologist and medical team. These patients receive a follow up letter a year after randomization, alerting them to the availability of clinical Lynch Syndrome screening.

Detailed Description:

Screening tests for Hereditary Non-Polyposis Colorectal Cancer (HNPCC) [also called Lynch Syndrome], are among the few available validated genetic tests that have been recommended as an evidence-based practice that can save lives. However, more than half of patients who meet well-established and accepted screening criteria do not receive screening. This is a critical failure for patients and for the health-care delivery system because HNPCC mutation carriers are at exceptionally high risk for colorectal and other HNPCC-related cancers, and because clinical strategies can prevent future cancers, or provide early detection, for individuals affected with HNPCC and their relatives. HNPCC testing is also cost-effective compared to treating individuals with a diagnosis of colorectal cancer (CRC).

To address this shortfall in practice, our proposed research mobilizes the resources of an integrated health-delivery system with extensive electronic clinical data to implement and evaluate a new strategy to maximize screening of CRC patients for HPNCC. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group recommended that all newly diagnosed CRC patients be screened for HPNCC, but was not able to recommend a best-strategy to accomplish this aim. Therefore, using the Practical Robust Implementation and Sustainability Model (PRISM), developed by one of our co-investigators, to guide the analyses, the investigators will:

Aim #1: Conduct a randomized controlled trial to determine the effectiveness of a universal laboratory test-based HNPCC screening program compared to the current practice of physician referral and self-referral.

Aim #2: Elucidate patient, provider, and system factors important to success of implementation.

Aim #3: (revised and approved during year 1): To create, refine, and disseminate an implementation guide for HNPCC screening by combining the results from Aims 1-2 and the perspectives from informant interviews of key staff at future diverse dissemination-implementation sites: Case Western Reserve University, Oregon Health & Sciences University, MD Anderson Cancer Center, Dana-Farber Cancer Institute, Kaiser Permanente Georgia, Kaiser Permanente Hawaii, and Safety Net West Clinics. Addition to Aim 3: We will contribute materials to the LSSN website for dissemination of implementation materials.

This study aims to evaluate implementation of a novel HNPCC screening program and assess, for all stakeholders, facilitators and barriers to program implementation and success. Results from this study will help achieve the Healthy People 2020 objective of reducing CRC mortality. It will add to the growing literature in the increasingly important area of translating research findings into real-world practice, a subject of the NIH Roadmap. Many of the findings will be useful in other clinical areas and will be broadly applicable to other health care organizations aiming to improve access to genetic tests for cancers.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years old
  2. Kaiser Permanente member
  3. Referral or scheduled colon surgery
  4. No known cognitive impairments (e.g., Alzheimer's Disease) that would impact the ability to be consented
  5. English speaker
  6. Diagnosis of colon cancer

Exclusion Criteria:

  1. Under the age of 18
  2. Known cognitive impairment
  3. Inability to speak/understand English
  4. On the research exclusion list
  5. Known Lynch syndrome
  6. No diagnosis of colon cancer
  7. In hospice
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582841

Locations
United States, Oregon
Kaiser Permanente Northwest
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Kaiser Permanente
Case Western Reserve University
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
Vanderbilt University
Investigators
Principal Investigator: Katrina AB Goddard, PhD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01582841     History of Changes
Other Study ID Numbers: 1RO1CA140377-01A2
Study First Received: December 15, 2011
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Colon Cancer
Lynch Syndrome
Genetic Screening

Additional relevant MeSH terms:
Syndrome
Colorectal Neoplasms, Hereditary Nonpolyposis
Disease
Pathologic Processes
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014